A Prospective Pilot Study of the OP-1 Putty in Uninstrumented Posterolateral Fusions

Degenerative Lumbar Spondylolisthesis Clinical Trial

Official title:

A Prospective, Randomized, Controlled, Multicenter, Pilot Study of the OP-1 Putty in Uninstrumented Posterolateral Fusions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00679107
• Other study ID #: S99-01US
• Status: Completed
• Phase: N/A
• First received: May 13, 2008
• Last updated: June 9, 2011
• Start date: June 1999
• Est. completion date: July 2005

Study information

• Verified date: June 2011
• Source: Olympus Biotech Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will explore the use of OP-1 Putty in conjunction with surgical treatment for the treatment of spinal decompression and lumbar spinal fusion.

Description:

It is postulated that the addition of OP-1 Putty to autogenous bone will prove beneficial in the treatment of patients requiring decompression and lumbar spinal fusion. The Investigational system is intended to stimulate bone growth. It is indicated as an adjunct or a replacement for autograft in spinal fusion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2005
• Est. primary completion date: December 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 81 Years

Eligibility

Inclusion Criteria:

1. The subject has a diagnosis of Degenerative Lumbar Spondylolisthesis of Grade I or II with Spinal Stenosis demonstrated by medical history, physical examination a n d radiographic imaging.

2. The subject is a candidate for decompression and spinal fusion with the use of autograft from the iliac crest.

3. The subject requires one level lumbar fusion (L-3 to S-1).

4. The subject has a preoperative Oswestry Disability Index of 30-100.

Exclusion Criteria:

1. The subject has active spinal and/or systemic infection.

2. The subject is morbidly obese.

3. The subject has a known sensitivity to any component of the OP-1 Putty.

4. The subject has spinal instability measured on flexion / extension radiographs of greater than 50% translation of the vertebrae and greater than or equal to 20 degrees of angular motion.

5. The subject uses tobacco or nicotine or is prescribed steroids such as cortisone.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Degenerative Lumbar Spondylolisthesis
• Spondylolisthesis

Intervention

Device:
• Use of OP-1 Putty in Uninstrumented posterolateral fusion
Use of OP-1 Putty in Uninstrumented posterolateral fusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Olympus Biotech Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety, by comparison of the complications and neurological status within the OP-1treatment groups and the control group (autograft alone).		6 weeks; 3, 6, 9, 12, and 24 months	Yes
Secondary	Efficacy, by comparison of overall fusion success and time to fusion along with pain / function outcome within the OP-1 treatment groups and the control group (autograft alone).		6 weeks; 3, 6, 9, 12, and 24 months	No